Status:
UNKNOWN
Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment
Lead Sponsor:
Centro Hospitalar de Lisboa Central
Collaborating Sponsors:
Centro de Estudos de Doenças Crónicas
Baylor College of Medicine
Conditions:
Aortic Coarctation
Arterial Stiffness
Eligibility:
All Genders
8-35 years
Brief Summary
Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty or stent implantation. Although short-term results are excellent with all three treatment modalities, long ...
Detailed Description
Study overview. This cross-sectional prospective observational study of patients with CoA previously treated using one of three treatment modalities assesses if treatment type is associated with diffe...
Eligibility Criteria
Inclusion
- Diagnosis of isthmic coarctation of the aorta;
- Current age between 8 (to allow cooperation with study procedures) and 35 years (to avoid confounding by aging-related vascular dysfunction); and
- Treatment for CoA after 1994, after which all three modalities were in clinical use.
Exclusion
- Residual CoA defined by a systolic upper-to-lower extremity BP gradient\> 20mmHg;
- Co-morbidities that may independently affect vascular function, including associated significant congenital heart disease, history of known vasculopathy, genetic syndromes or other cardiovascular risk factors;
- History of two treatment types for CoA; and
- CoA types likely representing a different entity or patients amenable to one single treatment type (surgery), including atypical CoA site (such as mid-thoracic or abdominal), severe hypoplasia of the aortic arch, and an age of treatment \<1 year of age.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03262753
Start Date
June 1 2013
End Date
December 30 2017
Last Update
August 25 2017
Active Locations (1)
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1
Department of Pediatric Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central
Lisbon, Portugal, 1169-024